According to the World Malaria Report 2008, there were an estimated 10.6 million cases of malaria in India in 2006 
. Chloroquine is still the main treatment for uncomplicated malaria in India. The WHO ranks India first in terms of total numbers of cases of tuberculosis (TB). In 2007, there were more than 1.9 million new cases of TB in India 
. Isoniazid and rifampicin are considered powerful first line drugs for treatment of TB.
At a 12% failure rate, the quality of drugs in peri-urban pharmacies around Delhi is slightly worse than the Indian government's estimate (roughly 10%) and better than that estimated by the Indian pharmaceutical industry, as reported to the WHO. The quality of drugs in pharmacies around Chennai is slightly better, with only a 5% failure rate. Although the sample sizes are too small to make broad conclusions and/or generalizations about the quality of essential drugs in India, they provide at least one reasonable scenario of the cities sampled. The failures could be the result of deliberate counterfeiting, or substandard production, transport or storage. The authors discussed these results with several local counterfeit drug investigators. The conclusions of these discussions were as follows: The wide variation in failure rates among pharmacies (See ) suggests that most pharmacists are buying good quality drugs and storing them properly. However, some pharmacists are either buying, wittingly or unwittingly, substandard drugs, expired drugs that have had their packaging possibly re-stamped with new expiry dates, or are incapable or unwilling to store drugs correctly.
The 12% and 5% failure rates in Delhi and Chennai respectively are perhaps lower than expected, given that some WHO-reported data indicates it to be higher 
. This variation calls for a system of enforcement to maintain a certain minimum quality criteria. Given the heavy burden of TB and malaria in the country, it is pertinent that high quality drugs be made available to residents. A similar system for exporting drugs should also be in place.
The failure rates observed in this study could be good news, demonstrating improved performance driven by the Indian authorities in response to increased awareness of the regulatory gaps as revealed by the Mashelkar Report in 2003. However, it should be noted that the Indian government has called upon committees in the past to review the regulatory system and make recommendations for its improvement but “these recommendations have been implemented by the Government to some extent, but the core issues have remained unresolved 
.” The improvement in failure rates could also be the result of individuals, such as the recent Indian Health Minister, Anbumani Ramadoss from Tamil Nadu state (capital Chennai), who has championed combating substandard drugs and may have also contributed to the better performance of Chennai-sourced drugs in this study.
Sampled pharmacies were located in urban and peri-urban areas of Delhi and Chennai, which have both higher wealth (double the national average in Delhi) and more tightly enforced regulation compared with more rural areas. Regardless, a 12% or 5% failure rate of essential drugs poses a significant threat to the respective health of Delhi and Chennai residents, and if the results are indicative of the country as a whole, there is an even greater danger to far more people. Assuming all cases of malaria and TB were treated, even a 1% failure rate would mean over 100,000 patients would receive substandard drugs. If the failure rates observed in this study were indicative of the country as a whole, then just over a million patients would access substandard drugs for just these two diseases. This extrapolation is a likely scenario if this problem is not addressed.
Why are substandard drugs prevalent in India? The Mashelkar Report of 2003 noted, “the problems in the regulatory system in the country were primarily due to inadequate or weak drug control infrastructure at the State and Central level, inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially trained cadres for specific regulatory areas, non-existence of data bank and nonavailability of accurate information 
.” In addition, the division of labor between the central and state regulatory agencies creates inconsistencies in regulatory requirements and policies across the country. Individual states are responsible for licensing and monitoring domestic drug manufacturers for quality, and pursuing legal action against offenders. This federal structure means that India lacks national norms for drug quality, and that most of the quality policing is done at state level without uniformity of action. This means a manufacturer producing substandard drugs could receive approval in a state with weak controls, and its drugs could be sold anywhere in the country.
Other shortcomings of India's regulatory system include poor enforcement and outdated legislation. Legal proceedings are “far too complicated and lengthy; the process moves slowly and the conviction rate is low 
.” The 1940 Drugs and Cosmetics Act, which governs drug production and sale in India, “contains various provisions for effective punitive action against manufacturers and distributors 
.” For adulterated drugs that likely caused death or bodily harm, the Act's lack of specificity has led to its under-utilization.
Additionally, there are too few drug inspectors in India, while the number of licensed manufacturing and selling premises increases exponentially. Pharmacists are not required to register with professional bodies or state boards and do not need to continue education after their initial qualification. Furthermore, there is a strong culture of self-prescription in the country, enabled by pharmacists willing to sell drugs without a prescription.
There are some important ramifications for foreign buyers of Indian drugs. If within India's own borders, and in relatively prosperous cities (Delhi and Chennai), a proportion (12% and 5% respectively) of drugs are substandard for various reasons, an assumption of safety is probably premature for at least some of the drugs that India exports. While developed nations provide strict import quality controls, probably screening out suspect products, this is not the case for most of the developing world. At present, Indian state drug regulatory authorities issue export licenses as well as a Certificate of Pharmaceutical Product to facilitate such trade. In all probability this is insufficient government oversight. Dora Akunyili, former Director General of Nigeria's National Agency for Food and Drug Administration and Control, routinely complained about drugs coming into Nigeria from India and banned at least 25 Indian drug companies from exporting to Nigeria 
The Indian government should lead an effort to harmonize regulatory requirements across states and consolidate regulatory functions, as recommended by the WHO. It should also increase penalties for those involved in the sale of substandard products as recommended by the Mashelkar Committee. It could also consider requiring that all drug manufacturers receive licenses from the central government, even while allowing states with sufficient regulatory capacity to continue licensing sales establishments.
This pilot study calls for a larger study to explore the extent of the availability of substandard and counterfeit drugs in the market. It calls for an investigation of pharmacies located in different parts of the country - rural, semi-urban, peri-urban - where the problem may be more rampant due to less stringent drug quality enforcement. It also calls for an internal Indian review of the counterfeit drug problem to tackle the TB, HIV/AIDS and malaria epidemics in the country.